We cannot offer any additional commentary because the Firm was part of the team representing defendant, but we wanted to commend to our readers the recent decision, In re Zofran (Ondansetron) Prod. Liab. Litig., 57 F.4th 327 (1st Cir. 2023). The case arises in the MDL related to the FDA-approved drug Zofran, and plaintiffs’ allegations that use during pregnancy caused birth defects. After years of litigation, the United States District Court for the District of Massachusetts, F. Dennis Saylor IV, Chief Judge, 541 F.Supp.3d 164, entered summary judgment for the former manufacturer on the basis of the doctrine of preemption. Defendant argued that the FDA had been fully informed of the alleged risks of the drug, and by, inter alia, approving an updated label for the current manufacture — not containing the additional warnings plaintiffs had demanded — the agency had clearly found the prior label adequate in this regard.
The First Circuit affirmed, noting that certain Japanese animal studies of the anti-emetic drug did not reveal any risks of teratogenicity, i.e., a drug’s ability to cause defects in a developing fetus, that prior studies shared with the FDA did not already discuss, and thus these animal studies did not constitute “newly acquired information” that would have required the drug’s manufacturer to make use of the Changes Being Effected (CBE) procedure to amend the label unilaterally. Indeed, the investigators in those studies concluded that the observed anomalies in the animal subjects were not dose-related and there was no evidence of teratogenicity.
The appeals court also concluded that even if the manufacturer could have invoked the CBE procedure to change the label to state that animal studies showed some evidence of teratogenicity, the FDA would have rejected such a change, because when approving an updated label for the later owner of the drug, the FDA approved a statement that the data revealed no significant effects of the drug on maternal animals or the development of offspring.
Worth a look as part of the new post-Albrecht landscape.